WO2008104996A2 - Formulation pharmaceutique pouvant se disperser dans l'eau et son procédé de préparation - Google Patents

Formulation pharmaceutique pouvant se disperser dans l'eau et son procédé de préparation Download PDF

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Publication number
WO2008104996A2
WO2008104996A2 PCT/IN2008/000111 IN2008000111W WO2008104996A2 WO 2008104996 A2 WO2008104996 A2 WO 2008104996A2 IN 2008000111 W IN2008000111 W IN 2008000111W WO 2008104996 A2 WO2008104996 A2 WO 2008104996A2
Authority
WO
WIPO (PCT)
Prior art keywords
water
tablet
water dispersible
agents
pharmaceutically acceptable
Prior art date
Application number
PCT/IN2008/000111
Other languages
English (en)
Other versions
WO2008104996A4 (fr
WO2008104996A3 (fr
Inventor
Nagesh Nagaraju
Prakash Kumar Soni
Gour Mukherji
Original Assignee
Jubilant Organosys Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jubilant Organosys Limited filed Critical Jubilant Organosys Limited
Priority to US12/528,859 priority Critical patent/US20100016322A1/en
Publication of WO2008104996A2 publication Critical patent/WO2008104996A2/fr
Publication of WO2008104996A3 publication Critical patent/WO2008104996A3/fr
Publication of WO2008104996A4 publication Critical patent/WO2008104996A4/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Definitions

  • the present invention relates to a water dispersible compressed tablet of pharmaceutically active ingredient and its pharmaceutically acceptable salts, solvates, hydrates or polymorphs for oral administration.
  • the invention also provides a process for manufacturing said tablet.
  • US Application No. 20050238724 assigned to Teva Pharmaceutical Industries, discloses a tablet formulation containing lamotrigine, diluents, binders and disintegrants.
  • WO2004006917 assigned to Ranbaxy Laboratories, relates to a process for the preparation of a dispersible tablet dosage form comprising beta- lactam antibiotics for oral administration and a disintegrating agent being used both intragranularly and extragranularly.
  • pharmaceutically active ingredient may include, but not limited to, montelukast, lamotrigine, zolmitriptan, rizatriptan, sumatriptan, naratriptan, olanzapine, risperidone, cetirizine, ranitidine, diclofenac, domperidone, amoxicillin, ondansteron, granisteron, piroxicam, nebumetone, ibuprofen, naproxen, flurbiprofen, diclofenac, acyclovir, deferacorix, acetaminophen, desloratadine, fexofenadine, levodopa, carbidopa, delavirdine, doxycycline, cefixime, oxcarbazepine, famotidine, metformin, glipizide, clarithromycin, azithromycin, cyclandelate, mirtazapine, 5-HT
  • dispenser tablet is meant a tablet, which disperses in aqueous phase, for example, in water before administration.
  • a water-dispersible tablet according to the British
  • a water dispersible compressed tablet can comprise about 0.01% to 50% w/w of montelukast or its pharmaceutically acceptable salts, solvates, hydrates or polymorphs, about 5% to about 50% w/w of a water-soluble diluent(s), about 35% to about 70 % w/w of a water swellable diluent(s), optionally one or more pharmaceutically acceptable adjuvants, wherein the ratio of water-soluble diluent(s) to water swellable diluent(s) is from about 0.6 to about 0.9 and said tablet is essentially free of disintegrant or superdisintegrant or swellable clay.
  • Lubricants and glidants are adjuvants used in the formula to reduce inter-particle and die-wall friction and enhance the powder flow due to their large surface area.
  • Suitable examples of lubricants include, but are not limited to, talc, magnesium stearate, calcium stearate, zinc stearate, sodium lauryl sulphate, sodium stearyl fumarate (Pruv), glyceryl behenate, stearic acid, polyethylene glycol, glyceryl palmitostearate and monostearate and the like.
  • the preferred lubricant is magnesium stearate. Magnesium stearate is commercially available from Mallinkrodt.
  • the lubricant may be present from about 0.1% to about 5% by weight of the tablet, particularly about 0.5 to about 4% and more particularly about 1% to about 3% by weight of the tablet.
  • Suitable glidants of the present invention include, but are not limited to, talc, colloidal silicon dioxide, amorphous silicon dioxide, magnesium silicate and calcium silicate.
  • the preferred glidant is colloidal silicon dioxide.
  • Colloidal silicon dioxide is commercially available from Degussa, Germany, under the brand name, Aerosil ® .
  • amorphous silicon dioxide is commercially available as RxCIPIENTS ® and Syloid ® 244 FP from J.M.Huber Corporation, USA and Grace GmbH, Germany, respectively.
  • Preferably glidants are used in an amount of about 0.1 to about 5% and more preferably about 0.5 to about 3% by weight of the tablet.
  • Disintegration time is the time for the tablet to disintegrate in water at room temperature in a disintegration time device.
  • the hardness of the tablet of the present invention remains substantially constant and leads to constant dispersion time.
  • the tablets prepared by these processes or operations have sufficient hardness and less friability to withstand handling and storage.
  • the tablet has a friability of 2% or less, particularly 1% or less, and more particularly 0.5% or less.
  • the tablet disperses quickly in water to give a fine dispersion, which is free from chalkiness and provides the intended dose uniformly.
  • the tablets can also be swallowed as such like conventional tablets.
  • the tablet disperses completely in water in about 2 minutes, preferably in about 1 minute.
  • step 2 The blend of step 1 was sifted through ASTM#40 mesh and uniformly mixed in a double cone blender for 10 minutes.
  • step 2 The blend of step 1 was sifted through ASTM#40 mesh and uniformly mixed in a double cone blender for 12 minutes.
  • step 3 The blend of step 3 was compressed using flat-faced beveled edge punches to form compressed tablets.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne un cachet comprimé pouvant se disperser dans l'eau et un procédé permettant de préparer celui-ci. Ledit cachet comprend environ 0,1 à 50 % p/p de lamotrigine ou de ses sels, ses solvates, ses hydrates ou ses polymorphes pharmaceutiquement acceptables, environ 5 à environ 50 % p/p d'un ou de plusieurs diluants solubles dans l'eau, environ 15 à environ 70 % p/p d'un ou de plusieurs diluants pouvant gonfler dans l'eau, et éventuellement un ou plusieurs adjuvants pharmaceutiquement acceptables. Le rapport entre le ou les diluants solubles dans l'eau et le ou les diluants pouvant gonfler dans l'eau étant compris entre environ 0,6 et environ 0,9. Ladite composition est essentiellement sans délitant, sans superdésintegrant et sans argile gonflant dans l'eau.
PCT/IN2008/000111 2007-02-28 2008-02-27 Formulation pharmaceutique pouvant se disperser dans l'eau et son procédé de préparation WO2008104996A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US12/528,859 US20100016322A1 (en) 2007-02-28 2008-02-27 Water Dispersible Pharmaceutical Formulation and Process for Preparing The Same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN444/DEL/2007 2007-02-28
IN444DE2007 2007-02-28

Publications (3)

Publication Number Publication Date
WO2008104996A2 true WO2008104996A2 (fr) 2008-09-04
WO2008104996A3 WO2008104996A3 (fr) 2008-12-11
WO2008104996A4 WO2008104996A4 (fr) 2009-01-29

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Country Status (2)

Country Link
US (1) US20100016322A1 (fr)
WO (1) WO2008104996A2 (fr)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009063484A2 (fr) * 2007-08-03 2009-05-22 Alkem Laboratories Ltd Composition pharmaceutique stable de lamotrigine et procede de preparation associe
EP2246046A1 (fr) * 2009-04-28 2010-11-03 Sanovel Ilac Sanayi ve Ticaret A.S. Comprimé d'olanzapine à désintégration orale
US20120004321A1 (en) * 2009-03-16 2012-01-05 Nipro Corporation Orally Disintegrating Tablet
WO2012003987A1 (fr) 2010-07-08 2012-01-12 Ratiopharm Gmbh Forme posologique orale de déférasirox
CN103919782A (zh) * 2013-01-15 2014-07-16 天津药物研究院 一种含有奥氮平的药物组合物及其制备方法
CN104337778A (zh) * 2013-07-25 2015-02-11 哈药集团三精制药股份有限公司 一种克拉霉素分散片的制备方法
US9119793B1 (en) 2011-06-28 2015-09-01 Medicis Pharmaceutical Corporation Gastroretentive dosage forms for doxycycline
CN105078920A (zh) * 2014-05-16 2015-11-25 山东司邦得制药有限公司 一种阿奇霉素胶囊及其制备方法
JP2017520627A (ja) * 2014-08-17 2017-07-27 山西振東安特生物製薬有限公司Ｓｈａｎｘｉ Ｚｈｅｎｄｏｎｇ Ａｎｔｅ Ｂｉｏｐｈａｒｍａｃｅｕｔｉｃａｌ Ｃｏ．，Ｌｔｄ． コロイドビスマスペクチンを含有する分散製剤及びその製造方法
CN108853038A (zh) * 2018-08-06 2018-11-23 成都通德药业有限公司 一种对乙酰氨基酚片及其制备工艺
CN110368367A (zh) * 2019-08-27 2019-10-25 佛山市南海东方澳龙制药有限公司 盐酸多西环素片剂及其制备方法和应用、抗菌药物
US10603272B2 (en) 2015-02-27 2020-03-31 Kindred Biosciences, Inc. Stimulation of appetite and treatment of anorexia in dogs and cats
WO2020210663A1 (fr) * 2019-04-12 2020-10-15 Ptc Therapeutics Inc. Composition de comprimé dispersible
US10842802B2 (en) 2013-03-15 2020-11-24 Medicis Pharmaceutical Corporation Controlled release pharmaceutical dosage forms
EP3804697A1 (fr) * 2019-10-12 2021-04-14 MEDITOP Gyógyszeripari Kft. Combinaison de préparation pharmaceutique pour application orale comprenant de la lamotrigine et de la sertraline, sa préparation et son utilisation

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Publication number Priority date Publication date Assignee Title
ES2400446T5 (es) 2006-08-03 2017-03-13 Horizon Pharma Ag Tratamiento con glucocorticoides de liberación retardada de una enfermedad reumática
US11006629B2 (en) 2008-11-20 2021-05-18 Armis Biopharma, Inc. Antimicrobial, disinfecting, and wound healing compositions and methods for producing and using the same
EP2391369A1 (fr) * 2009-01-26 2011-12-07 Nitec Pharma AG Traitement de l'asthme par glucocorticoïde à libération retardée
EP3525792A4 (fr) * 2016-10-11 2020-04-22 Aucta Pharmaceuticals Poudre pour suspension orale contenant de la lamotrigine
US20210077438A1 (en) 2017-07-07 2021-03-18 Armis Biopharma, Inc. Compositions and methods for remediating chemical warfare agent exposure and surface decontamination
CN114302728A (zh) * 2019-08-26 2022-04-08 帝斯曼知识产权资产管理有限公司 包含萘普生和维生素b12的固体口服剂型

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WO1996017611A1 (fr) * 1994-12-07 1996-06-13 The Wellcome Foundation Limited Composition pharmaceutique contenant de la lamotrigine
WO1998046213A1 (fr) * 1997-04-17 1998-10-22 Bristol-Myers Squibb Company Formulation de comprimes de monohydrate de cefadroxil
WO1999032092A1 (fr) * 1997-12-19 1999-07-01 Smithkline Beecham Corporation Comprimes a dispersion rapide
WO2005051350A2 (fr) * 2003-10-28 2005-06-09 Torrent Pharmaceuticals Limited Comprime dispersible dans l'eau
WO2005067976A2 (fr) * 2004-01-20 2005-07-28 Novartis Ag Formulation a compression directe et procede correspondant

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EP1496864B1 (fr) * 2002-04-23 2007-03-21 Teva Pharmaceutical Industries Ltd. Composition pharmaceutique contenant des particules de lamotrigine de morphologie definie
CN1323667C (zh) * 2004-08-04 2007-07-04 云南白药集团股份有限公司 三七分散片及其制备方法
US20100226979A1 (en) * 2006-03-21 2010-09-09 Jubilant Organosys Limited Taste Masked Phamaceutical Composition for Oral Solid Dosage form and Process for Preparing the Same Using Magnesium Aluminium Silicate

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996017611A1 (fr) * 1994-12-07 1996-06-13 The Wellcome Foundation Limited Composition pharmaceutique contenant de la lamotrigine
WO1998046213A1 (fr) * 1997-04-17 1998-10-22 Bristol-Myers Squibb Company Formulation de comprimes de monohydrate de cefadroxil
WO1999032092A1 (fr) * 1997-12-19 1999-07-01 Smithkline Beecham Corporation Comprimes a dispersion rapide
WO2005051350A2 (fr) * 2003-10-28 2005-06-09 Torrent Pharmaceuticals Limited Comprime dispersible dans l'eau
WO2005067976A2 (fr) * 2004-01-20 2005-07-28 Novartis Ag Formulation a compression directe et procede correspondant

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DATABASE WPI Week 200655 Thomson Scientific, London, GB; AN 2006-530248 XP002496240 & CN 1 730 007 A (YUNNAN BAIYAO GROUP CO LTD) 8 February 2006 (2006-02-08) *

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009063484A2 (fr) * 2007-08-03 2009-05-22 Alkem Laboratories Ltd Composition pharmaceutique stable de lamotrigine et procede de preparation associe
WO2009063484A3 (fr) * 2007-08-03 2009-07-02 Alkem Lab Ltd Composition pharmaceutique stable de lamotrigine et procede de preparation associe
US20120004321A1 (en) * 2009-03-16 2012-01-05 Nipro Corporation Orally Disintegrating Tablet
EP2246046A1 (fr) * 2009-04-28 2010-11-03 Sanovel Ilac Sanayi ve Ticaret A.S. Comprimé d'olanzapine à désintégration orale
TR200903293A1 (tr) * 2009-04-28 2010-11-22 Sanovel İlaç San. Ve Ti̇c. A.Ş. Oral yolla dağılan olanzapin tablet.
WO2012003987A1 (fr) 2010-07-08 2012-01-12 Ratiopharm Gmbh Forme posologique orale de déférasirox
EP2929877A1 (fr) 2010-07-08 2015-10-14 ratiopharm GmbH Forme posologique orale de déférasirox
US9119793B1 (en) 2011-06-28 2015-09-01 Medicis Pharmaceutical Corporation Gastroretentive dosage forms for doxycycline
CN103919782A (zh) * 2013-01-15 2014-07-16 天津药物研究院 一种含有奥氮平的药物组合物及其制备方法
US10842802B2 (en) 2013-03-15 2020-11-24 Medicis Pharmaceutical Corporation Controlled release pharmaceutical dosage forms
CN104337778A (zh) * 2013-07-25 2015-02-11 哈药集团三精制药股份有限公司 一种克拉霉素分散片的制备方法
CN105078920A (zh) * 2014-05-16 2015-11-25 山东司邦得制药有限公司 一种阿奇霉素胶囊及其制备方法
JP2017520627A (ja) * 2014-08-17 2017-07-27 山西振東安特生物製薬有限公司Ｓｈａｎｘｉ Ｚｈｅｎｄｏｎｇ Ａｎｔｅ Ｂｉｏｐｈａｒｍａｃｅｕｔｉｃａｌ Ｃｏ．，Ｌｔｄ． コロイドビスマスペクチンを含有する分散製剤及びその製造方法
US10603272B2 (en) 2015-02-27 2020-03-31 Kindred Biosciences, Inc. Stimulation of appetite and treatment of anorexia in dogs and cats
CN108853038A (zh) * 2018-08-06 2018-11-23 成都通德药业有限公司 一种对乙酰氨基酚片及其制备工艺
WO2020210663A1 (fr) * 2019-04-12 2020-10-15 Ptc Therapeutics Inc. Composition de comprimé dispersible
CN110368367A (zh) * 2019-08-27 2019-10-25 佛山市南海东方澳龙制药有限公司 盐酸多西环素片剂及其制备方法和应用、抗菌药物
CN110368367B (zh) * 2019-08-27 2021-07-27 佛山市南海东方澳龙制药有限公司 盐酸多西环素片剂及其制备方法和应用、抗菌药物
EP3804697A1 (fr) * 2019-10-12 2021-04-14 MEDITOP Gyógyszeripari Kft. Combinaison de préparation pharmaceutique pour application orale comprenant de la lamotrigine et de la sertraline, sa préparation et son utilisation

Also Published As

Publication number Publication date
WO2008104996A4 (fr) 2009-01-29
US20100016322A1 (en) 2010-01-21
WO2008104996A3 (fr) 2008-12-11

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